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510(k) K251128

Extremity Medical External Fixation System by Extremity Medical, LLC — Product Code KTT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 7, 2025
Date Received
April 11, 2025
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component
Device Class
Class II
Regulation Number
888.3030
Review Panel
OR
Submission Type

Other clearances by Extremity Medical, LLC

  • K250536 — MetaFore Small Screw System (October 8, 2025)
  • K241563 — Extremity Medical External Fixation System (February 21, 2025)
  • K212297 — Omni Foot and Ankle Plating System (August 20, 2021)
  • K211261 — Axis Charcot Fixation System (May 28, 2021)
  • K201556 — Intraosseous Fixation System (July 8, 2020)
  • K191525 — KinematX Total Wrist Arthroplasty System (March 4, 2020)
  • K192592 — Axis Plating System (November 21, 2019)
  • K181067 — AlignX Ankle Fusion System (May 23, 2018)
  • K180808 — Omni Foot Plating System (May 22, 2018)
  • K172260 — Omni Foot Plating System (November 6, 2017)

Other clearances for product code KTT

  • K253291 — Excelsior System (January 20, 2026)
  • K253613 — Monkey Rings External Ring Fixation System (December 19, 2025)
  • K253202 — Hoffmann LRF System (December 19, 2025)
  • K252555 — Medusa Orthopedics Boa External Fixation System (November 25, 2025)
  • K252625 — The Response Ortho Smart Fixator - Hexapod System (November 20, 2025)
  • K252106 — External Fixation Mini Rail System (September 30, 2025)
  • K251862 — External Fixation Bone Distractor (August 11, 2025)
  • K250472 — SixFix™ Hexapod Fixator and Deformity Analysis and Correction Software (DACS) (August 8, 2025)
  • K243798 — Orthex External Fixation System (March 7, 2025)
  • K241563 — Extremity Medical External Fixation System (February 21, 2025)